Early Results: In Children, 2009 H1N1 Influenza Vaccine Works Like Seasonal Flu Vaccine
Early results from a trial testing a 2009 H1N1 influenza vaccine in children look promising, according to the trial sponsor, the National Institute of Allergy and Infectious Diseases.
Balintfy: An ongoing trial being conducted in healthy children from 6 months to 17 years old is showing that the 2009 H1N1 influenza vaccine is acting just like the seasonal flu vaccine.
Dr. Fauci: The initial results are encouraging.
Balintfy: Dr. Anthony Fauci is director of National Institute of Allergy and Infectious Diseases.
Dr. Fauci: The trial is testing two different dosages (15 versus 30 micrograms) and evaluating the immune response to one and two doses of 2009 H1N1 influenza vaccine.
Balintfy: On August 7th NIAID launched the first of a series of vaccine trials of 2009 H1N1 influenza vaccines in healthy adults and elderly individuals. After a review of early data from the adult trials found no safety concerns, trials began in healthy children in mid-August.
Dr. Fauci: Preliminary data from our trials indicate that a single 15-microgram dose of vaccine is well-tolerated and induces an immune response in most older children, that is generally predictive of protection.
Balintfy: Early analysis of blood samples from a small group of trial participants shows that a single 15-microgram dose of the 2009 H1N1 influenza vaccine—the same dose that is in the seasonal flu vaccine—generates an immune response that is expected to be protective in the majority of 10- to 17- year-olds.
Dr. Fauci: The response in younger children is less robust, but that is not unexpected, as this is the case with seasonal flu vaccines as well.
Balintfy: Data from the trial is being compared for three age groups: children 6 months to 35 months; 3 to 9 years; and 10 to 17 years old.Dr. Fauci: Although the data are drawn from an early time point—only 8-10 days after vaccination—they also suggest that the two younger groups, that is, children from 6 months to 9 years old, may require two doses of the vaccine, depending on their health history. This is not an unexpected finding and quite similar to what we see with seasonal flu vaccine and is in accordance with the FDA's recommendations for seasonal flu vaccine in children of various ages.
Balintfy: NIAID is conducting trials of 2009 H1N1 influenza vaccines through its longstanding vaccine clinical trials network. The 2009 H1N1 influenza vaccine, like inactivated seasonal flu vaccines, contains a purified part of a killed virus and cannot cause flu. For more information on influenza, including H1N1, visit www.flu.gov. This is Joe Balintfy, National Institutes of Health, Bethesda, Maryland.
About This Audio Report
Reporter: Joe Balintfy
Sound Bite: Dr. Anthony Fauci
Topic: H1N1, flu, influenza, vaccine, children